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Clinical Trials in Mexico / NCT05074264
Active, not recruiting Not applicable

Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico

NCT05074264 · tracked via the Priya Life Science Mexico tracker
Sponsor
University of California, San Francisco
Phase
Not applicable
Started
2021-11-30
Last updated
2026-08-24

Condition(s) studied

AIDS-Related Anal CarcinomaAIDS-Related Cervical CarcinomaHigh Grade Anal Intraepithelial NeoplasiaHigh Grade Cervical Intraepithelial NeoplasiaHIV Infection

Investigational drug(s) / intervention(s)

BiopsyBiospecimen Collection - AnalBiospecimen Collection - CervicalColposcopyHigh Resolution AnoscopyImaging Technique

Biopsy: Undergo biopsy

Biospecimen Collection - Anal: Undergo collection of anal swabs

Biospecimen Collection - Cervical: Undergo collection of cervical swabs

Colposcopy: Undergo colposcopy

High Resolution Anoscopy: Undergo high-resolution anoscopy

Imaging Technique: Undergo cervical imaging

Study summary

This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Patients with HIV are at high risk of becoming infected with human papillomavirus (HPV) in the cervix or anus where it can turn into cancer over several years. HPV causes changes to the cervix and anus, known as HSIL. This means that there is an area of abnormal tissue on the top layers of the cervix or anus. It is considered cervical or anal cancer if the abnormality spreads down into the layers of tissue below the top. If found early, many cases of HSIL can be treated before turning into cancer. Screening for cervical or anal cancer detection or HSIL associated with HPV may result in earlier treatment, if necessary, for patients living with HIV.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Documentation of HIV-1 infection by means of any one of the following: * Documentation of HIV diagnosis in the medical record by a licensed health care provider * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \[e.g., Truvada\], which is exclusionary); * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \> 1000 RNA copies/mL * Any locally licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay * NOTE: A "licensed" assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay or an assay approved by the relevant local health authority * Age 21 years or older. Cervical HSIL/cancer screening does not usually begin until 20 years of age or older. Also, anal HSIL/cancer screening among high risk individuals such as people living with HIV is recommended for those 25 years of age or older. Children under the age of 18 are at low risk of developing cervical or anal HSIL/cancer and will not benefit from the kind of screening planned for this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky score \>= 70%) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who have undergone hysterectomy * History of anal cancer, penile, vulvar, vaginal, or cervical cancer * Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment * Inability in the opinion of the study investigator of the participant to comply with study requirements * Participants who are pregnant (a urine pregnancy test will be provided to participants aged 60 years or less) or within 2 months being post-partum

Primary outcome measure(s)

  • Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL) — Up to 3 years
    Will assess a screening algorithm with an optimal combination of: point of care high-risk (hr) HPV testing, extended hrHPV genotyping, cytology, progression markers protein E6 and S5 methylation score, to identify cervical and/or anal HSIL or cancer. Different contingency tables will be prepared to describe the statistical relationship between hrHPV infection and HSIL positive status. Using the Bayes Rule, the predicted values will the computed using the prevalence of HSIL positive (overall and per country), where prevalence is the probability of currently being HSIL positive regardless of the duration of time one has the disease. The positive Diagnostic Likelihood Ratios (DLR) and the Negative Diagnostic Likelihood Ratio will be computed to determine the best strategy combining sensitivity and specificity. The 95% confidence intervals of DLR+ will be computed using the log approach.

Trial sites (4)

FacilityCityRegionStatus
Condesa Specialized Clinic Mexico City Mexico City
Condesa Iztapalapa Specialized Clinic Mexico City Mexico City
Instituto Nacional de Cancerologia (INCan) Mexico City Mexico City
University of Puerto Rico Comprehensive Cancer Center San Juan PR

More University of California, San Francisco trials in Mexico

Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH) Active, not recruiting
Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico Enrolling by invitation

Other trials for the same condition

Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico Recruiting
Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience Recruiting
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Compared With Darunavir/Cobicistat Plus Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed People Living With HIV at 24 and 48 Weeks of Follow-up Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05074264 on ClinicalTrials.gov ↗ ← All trials in Mexico